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Upholding Quality Compounding Practices

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The Australian Society of Compounding Pharmacists (ASCP) stands firm in its commitment to the upholding of regulations, guidelines, and standards governing the practice of quality compounding. Our organisation serves as a dedicated advocate for striking the delicate balance between regulatory measures and ensuring uninterrupted patient access to essential medicines.

We stress our support of the current regulatory framework, which offers comprehensive guidelines for both sterile and non-sterile compounding processes. Pharmacists are urged to conduct thorough risk assessments of all facets of compounding practice, ensuring strict adherence to the guidelines outlined by the Pharmacy Board of Australia in the Guidelines on compounding of medicines.

This includes meticulous consideration of compounding circumstances, coupled with the provision of evidence pertaining to the efficacy, safety, quality, and stability of compounded medications.

Pharmacists who prepare sterile compounded medicines are reminded that the revised USP General Chapter <797> for Sterile Compounding, which came into force on 1st November, 2023, is the appropriate guidance document which must be adhered to, unless they are following PIC/S Guide to Good Manufacturing Practice. We highlight the importance of adhering to guidelines and standards, when compounding high risk medications such as sterile medicines, including GLP-1 RAs during times of medication shortage, in order to serve patients’ identified needs.

Membership to ASCP is available at www.ascp.net.au.